In 2018, an estimated 266,000 new cases of invasive breast cancer and 64,000 cases of in situ breast cancer in women, and 2550 new cases in men, are expected to be diagnosed in the United States. The majority of these individuals will seek medical treatment for their disease. Women diagnosed with early stage breast cancer have several options for treatment. The surgical options include mastectomy, with or without reconstruction, or lumpectomy followed by radiation therapy and possibly chemotherapy. MA data from 2000-2007 indicates that approximately 30% to 40% of women undergo mastectomy with or without reconstruction. Most male patients undergo mastectomy alone.
The majority of patients undergoing mastectomy will have a simple, skin-sparing mastectomy, whereby the breast tissue is removed and underlying muscle and overlying skin are spared. The extent and type of surgical procedure used depends upon the staging of the tumor, patient preferences, and the physician's skills for reconstruction. Axillary lymph node sampling via sentinal node detection and removal is standard procedure; however, axillary lymph node dissection and removal are still indicated when gross disease is present.
Removing breast tissue (with or without immediate reconstruction) and lymph nodes leads to the accumulation of serous fluid in the chest region and local tissues. During the recovery process, the body slowly develops collateral drainage that removes this excess fluid from the tissues. Surgical drains are implanted to assist in serous/serosanguinous fluid removal. The drains reduce the incidence of post-operative complications and morbidity from infection, hematoma formation, and skin-flap compromise.
One or more drains (e.g., Jackson-Pratt (“JP”) drain, etc.) are surgically implanted near each operative site to drain serous lymphatic fluid as well as some blood that accumulates after the mastectomy or breast surgery. The drains include about a meter of flexible tubing that transports fluid from the surgical site to a bulbous reservoir (“collection bulb”). A perforated collection tube lies under the skin; most of the tubing and the collection bulb are extracorporeal.
The tubing is sutured to the skin at its point of exit from the body. This point of exit varies for each mastectomy case; the surgeon chooses the exit site for the drain tubing at the time of mastectomy based on individual body habitus and the type of surgical reconstruction used. The tubing's exit location can vary from right side to left side of the body, but is generally located to the lateral side of the mastectomy site near the axillary region. The drains remain in place collecting fluid for one week to as long as a month or more. The patient is responsible for daily maintenance of the drains, which includes emptying the collection bulb approximately 4 times daily. Once serous drainage diminishes to a point at which the body can reabsorb the fluid, the drains are removed.
Although the drains serve an important and necessary function, they are a source of discomfort for many patients. During daily activities, the weight of the collection bulb and the presence of dangling tubing often results in pain-provoking tension at the exit point due to the sutures. A variety of post-operative garments have been proposed to address this and other issues, including, for example: U.S. Pat. Nos. 5,429,593, 6,032,289, 6,055,668, and U.S. Publ. Pat. Appls. 2006/0173427 and 2011/0041231.
The garments disclosed in the aforementioned patent documents are intended to be suitable for both men and women; in some cases the garment must be modified for anatomical differences, in other cases not. For example, the garments disclosed in U.S. Pat. No. 5,429,593 and U.S. Publ. Pat. Appl. 2006/0173427 are unsuitable for use as a brassiere (and hence provide limited utility for a female patient). The garment disclosed in U.S. Pat. No. 6,032,289 is supposedly capable of being modified into the form of a brassiere. U.S. Publ. Pat. Appl. 2011/0041231 discloses a smock-like garment that can have a bra-like attachment fitted thereto. U.S. Pat. No. 6,055,668 discloses a bra-like garment that can be made with cups (for women) or without cups (for men). Designed to be useful for both men and women, the aforementioned garments are a poor substitute for a brassiere.
Unlike the references discussed above, U.S. Pat. No. 6,390,885 discloses a garment that is intended exclusively for women—a surgical-recovery brassiere. The brassiere includes several drain tube apertures that are sized to permit the flexible tubing of a drain to pass through the side panel. A storage pouch is disposed at the lower edge of the brassiere to receive the collection bulbs of the drains. The pouch includes divided pockets and has an elastic top entry so that the collection bulbs can be readily accessed for drainage. This garment does not take into account changes in surgical procedures during the last decade, such as variation in drain exit points.
Over the last ten years there have been a number of developments in breast surgery; for example, novel surgical techniques, the use of human acellular dermal matrix, direct-to-implant reconstruction or delayed two-stage reconstruction involving expanders and implant exchange. Many of the post-surgical garments (e.g., brassieres, etc.) discussed above are poorly adapted to accommodate these developments. In particular, and among other drawbacks, a number of prior-art, post-surgery brassieres function as complete compressive wraps. With the advent of, for example, direct-to-implant reconstruction, such indiscriminately applied compression is undesirable.
Applicant has developed a post-surgery brassiere that addresses some of the aforementioned issues. It is commercially available at https://mastheadpink.com/bras/ as the ELIZABETH PINK SURGICAL BRA® brand post-surgical brassiere. FIG. 1 depicts, as prior-art post-surgery bra 100, the aforementioned ELIZABETH PINK SURGICAL BRA®.
Bra 100 includes cups 102A and 102B, shoulder straps 104A and 104B, and back band 108. Bra 100 includes several release points, including medial closure 110, superior closures 106A and 106B, which are situated along respective shoulder straps 104A and 104B, and side closures 116, one of which is disposed between backband 108 and cup 102A and the other between the backband and cup 102B. The release points are implemented as hook-and loop fastener 112 (i.e., VELCRO™), which is shown for closure 110. Markings 118 serve as a scale/index for repeated, consistent positioning of the closure.
Side closures 116 form apertures 114. The apertures are positioned so that when the brassiere is in use, each aperture aligns with the side of the patient underneath each axilla (i.e., arm pit). Apertures 114 enable the extracorporeal flexible tubing of a drain (e.g., JP drain, etc.) to pass through the bra. The apertures are embodied as “plackets,” as opposed a hole through the side band, so that a user can don or remove the bra without removing the drain's collection bulb. To the extent that a bra includes a hole (as opposed to a placket), which is sized to permit passage of a collection bulb for a specific type of drain, it might be undersized to permit the passage of other bulbs from other drains. In such a case, this will require removing the collection bulb from the drain tube to remove the bra.
Base band 120 comprises an elastic material that is attached to the bottom edge of the cups 102A and 102B and back band 108. By virtue of its elasticity, base band 120 ensures that the bottom of the bra remains tight to the body when in use.
To support the extracorporeal portions of a JP drain, bra 100 includes two loops 122 of material, such as ribbon, etc., one of which is sewn to and hangs from base band 120 below each cup 102A and 102B. One openable retaining ring 124 couples to each loop 122. In the illustrative embodiment, retaining rings 124 comprises plastic. The retaining ring can be opened and closed to support the collection bulb and associated tubing of a drain.
FIG. 2 depicts the extracorporeal portions of a JP drain extending through one of apertures 114 of bra 100. In particular, drain tube 232, the hidden end of which extends into the patient's surgical site, couples to collection bulb 234 of the JP drain. The collection bulb collects excess lymphatic fluid that is withdrawn from the body via tube 232. As depicted, when bra 100 is in use, loop 236 of collection bulb 234 couples to retaining ring 124. As previously discussed, to couple retaining ring 124 to loop 236, the ring is opened, the loop 236 is positioned on the opened ring, and then the ring is closed.
This arrangement ensures that collection bulb 234 is supported and further that it hangs below the heart, as is required for best fluid drainage. Also, because the collection bulb is attached to the brassiere near its bottom edge, and because the drain tubing remains hidden underneath the patient's blouse, it is very unlikely that the drain tubing could snag on anything that would otherwise cause tension/tugging on the sutured skin at the insertion site. Furthermore, the drain bulb is not forced into an ill-fitting pocket, as in a number of prior-art post-surgery garments. As a consequence, pain and discomfort are minimized and accidental dislodgement of the tubing is prevented.
Applicant has also received U.S. Pat. No. 9,545,124 for a post-surgical brassiere specifically adapted for immobilizing the tubes of an after-loaded catheter/brachytherapy device.
In medicine as in many other fields, the state-of-the-art is advancing with increasing rapidity. This means a steady stream of new medical procedures and concomitant changes to the standard-of-care. In some cases, by the time a new medical device is approved, it's nearly out-of-date. Also, hospital physicians will often use what they have on hand to address a problem, particularly if an application-specific device is not available. For example, although bra 100 was designed with a focus on recovery from breast surgery, it has been used in hospitals to decrease patient morbidity and improve patient comfort in a variety of other applications in which it is necessary to drain fluids from patients. Typical examples include post cardiac and thoracic surgery. But because it was designed with a single application in mind, bra 100 lacks a certain flexibility that would make it that much for suitable for such other applications.
Consequently, it is desirable that new medical devices be designed, to the extent possible, to be broadly applicable and adaptable.